Baystate Takes Part in Pioneering Study on Natural Orifice Surgery

SPRINGFIELD — Surgeons at Baystate Medical Center have enrolled the first patient in a national, multi-center study of the potential for a new surgical technique to be as effective and safe as traditional approaches, while at the same time reducing recovery time, infection rates, post-surgical scarring, and perhaps even health costs.

Baystate is a leading hospital in developing and practicing NOTES — natural orifice translumenal endoscopic surgery — which uses tiny cuts, or no external cuts at all, to remove diseased tissue from the body’s internal cavity. With NOTES, surgeons extract tissue through the patient’s natural body openings, usually the mouth or vagina, using tiny cameras and surgical tools manipulated with extreme precision.

By minimizing incisions and decreasing the body cavity’s exposure to external bacteria, NOTES has the potential to revolutionize modern surgery, as shorter hospital stays and lower complication rates would could significantly improve patient satisfaction and help control health costs, as well.

But first, doctors need to be sure the new technique is just as safe as current approaches, so Baystate and other academic medical centers across the country are enrolling 140 patients in a rigorous test of NOTES’ effectiveness.

“We know from our experience that NOTES can be very effective for procedures like cholecystectomy [surgical removal of the gallbladder],” said Dr. John Romanelli, director of Bariatric Surgery and Robotic Surgery at Baystate Medical Center and a pioneer in the field of minimally invasive surgery. “This multi-center clinical trial is an extremely important step in determining whether NOTES can be safe and effective for an exponentially greater number of patients, and we’re proud to be at the forefront of this study.”

In June 2007, Romanelli and Dr. David Desilets, chief of Gastroenterology at Baystate Medical Center, performed the world’s first stapled NOTES cyst-gastrostomy, passing an endoscope and surgical stapler through their patient’s mouth and down into his digestive tract to puncture and drain an infected pancreatic pseudocyst, resolving the patient’s life-threatening condition.

“Even since that operation, we have come a long way in terms of what we can do to minimize the impact of surgery on the patient’s body,” said Romanelli. “I believe that minimally invasive approaches like NOTES will, in the not-too-distant future, become the norm for some types of surgery.”

The NOTES study is an initiative of the Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR), a joint venture between the American Society for Gastrointestinal Endoscopy and the Society of American Gastrointestinal and Endoscopic Surgeons.

At first, trial sites will enroll patients to compare removal of the gall bladder. Patients will be randomized to receive NOTES (through either the vagina or the mouth) or traditional laparoscopic surgery in which removal occurs via cuts in the abdomen. While 1 million traditional laparoscopic procedures have been performed nationally, fewer than 1,000 have been done worldwide using NOTES.

There are opportunities for additional patients to participate in the trial at Baystate, as long as they are appropriate candidates, said Romanelli.